View all text of Part G [§ 360ddd - § 360ddd-2]
§ 360ddd–1. Regulation of medical gases
(a) Certification of designated medical gases
(1) Submission
Beginning 180 days after July 9, 2012, any person who seeks to initially introduce or deliver for introduction a designated medical gas into interstate commerce may file with the Secretary a request for certification of a medical gas as a designated medical gas. Any such request shall contain the following information:
(A) A description of the medical gas.
(B) The name and address of the sponsor.
(C) The name and address of the facility or facilities where the medical gas is or will be manufactured.
(D) Any other information deemed appropriate by the Secretary to determine whether the medical gas is a designated medical gas.
(2) Grant of certification
The certification requested under paragraph (1) is deemed to be granted unless, within 60 days of the filing of such request, the Secretary finds that—
(A) the medical gas subject to the certification is not a designated medical gas;
(B) the request does not contain the information required under paragraph (1) or otherwise lacks sufficient information to permit the Secretary to determine that the medical gas is a designated medical gas; or
(C) denying the request is necessary to protect the public health.
(3) Effect of certification
(A) In general
(i) Approved uses
A designated medical gas for which a certification is granted under paragraph (2) is deemed, alone or in combination, as medically appropriate, with another designated medical gas or gases for which a certification or certifications have been granted, to have in effect an approved application under section 355 or 360b of this title, subject to all applicable postapproval requirements, for the following indications for use:
(I) In the case of oxygen, the treatment or prevention of hypoxemia or hypoxia.(II) In the case of nitrogen, use in hypoxic challenge testing.(III) In the case of nitrous oxide, analgesia.(IV) In the case of carbon dioxide, use in extracorporeal membrane oxygenation therapy or respiratory stimulation.(V) In the case of helium, the treatment of upper airway obstruction or increased airway resistance.(VI) In the case of medical air, to reduce the risk of hyperoxia.(VII) In the case of carbon monoxide, use in lung diffusion testing.(VIII) Any other indication for use for a designated medical gas or combination of designated medical gases deemed appropriate by the Secretary, unless any period of exclusivity for a new drug under clause (iii) or (iv) of section 355(c)(3)(E) of this title, clause (iii) or (iv) of section 355(j)(5)(F) of this title, or section 360cc of this title, or the extension of any such period under section 355a of this title, applicable to such indication for use for such gas or combination of gases has not expired.(ii) Labeling
The requirements of sections 353(b)(4) and 352(f) of this title are deemed to have been met for a designated medical gas if the labeling on the final use container for such medical gas bears—
(I) the information required by section 353(b)(4) of this title;(II) a warning statement concerning the use of the medical gas as determined by the Secretary by regulation; and(III) appropriate directions and warnings concerning storage and handling.(B) Inapplicability of exclusivity provisions
(i) No exclusivity for a certified medical gas
(ii) Effect on certification
(4) Withdrawal, suspension, or revocation of approval
(A) Withdrawal, suspension of approval
(B) Revocation of certification
(b) Prescription requirement
(1) In general
(2) Oxygen
(A) No prescription required for certain uses
Notwithstanding paragraph (1), oxygen may be provided without a prescription for the following uses:
(i) For use in the event of depressurization or other environmental oxygen deficiency.
(ii) For oxygen deficiency or for use in emergency resuscitation, when administered by properly trained personnel.
(B) Labeling
(June 25, 1938, ch. 675, § 576, as added Pub. L. 112–144, title XI, § 1111, July 9, 2012, 126 Stat. 1109; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(S), Dec. 13, 2016, 130 Stat. 1155.)